1. Field of the Invention
The apparatus of the present invention relates to cervical speculums. More particularly, the present invention relates to an adapter and evacuation tube system which may be adapted to an existing cervical speculum, for drawing off excess fluid and smoke from a patient undergoing laser surgery in the treatment of vaginal related disorders.
2. General Background
In the therapy and treatment of disorders of the cervix, there is a developing technique chosen for outpatient therapy which is safe, and produces adequate cure-aids and is relatively inexpensive. The vast majority of vaginal intraepithelial neoplasia (CIN), lesions discovered in 80% of women screened for vaginal cancer or early small lesions located on the exposed portion of the cervix, may be managed on an out-patient basis. Although cryatherapy is a state of the art technique in the treatment of such pathology, in recent years, the carbon dioxide laser has gained in popularity in both private and institutional practices. It has been claimed that laser therapy for CIN yields higher cure rates and faster healing than cyrotherapy in that the squamocolumnar junction retains its location at the external OS following treatment. In addition, therapeutic success in the art of 95% after a single treatment and 99% after two lasers treatments have been reported.
One of the concerns in the treatment of vaginal condition through laser therapy is the problem surrounding the surgeons ability to properly perform laser surgery on the cervix due to the resultant stream of smoke that is emitted when the laser makes contact with human cells. This stream of smoke on one hand reduces a surgeon's ability to see properly the surgery being undertaken with the laser, and, on the other hand subjects the surgeon and surgical staff to cell fragments contained within the smoke or fluids which could be detrimental to the surgeon during such a technique.
As in all surgeries on the cervix, an instrument known as a speculum is utilized to increase the opening of the vagina so that the surgeon has relatively easy access to the area being treated. In fact, there are known speculums which do contain a tube attached to the blade of a speculum for either blowing air upon or siphoning off smoke that may be a result of electrical conization or cauterization upon the cervix, in order to overcome the presence of smoke in the vagina.
In view of the fact that most of the cervical speculums which are out on the market and being used, do not include any means for evacuating smoke or fluid during vaginal laser surgery, there is a need to provide a means whereby a surgeon may easily adapt a means for easily evacuating the smoke and fluid during the surgery, without having to discard the state of the art speculums which are presently being used by most if not all physicians during this type of medical treatment. In order to solve this problem, this speculum adapter has been devised for use under those particular circumstances. Several patents regarding speculums have been noted in the art, the most pertinent being as follows:
U.S. Pat. No. 2,483,233 issued to Price, et al, entitled "Speculum", relates to a speculum having a tube running in the upper jaw portion for blowing air into or for suctioning off smoke from the vagina following conization or cauterization upon the cervix.
U.S. Pat. No. 2,243,285, issued to Pope, entitled "Operating Scope", which is adapted for positioning of instruments therewithin, the scope adapted with a light source within the walls of the barrel for aspirating fluids therefrom.
U.S. Pat. No. 3,037,505, issued to Walden, entitled "Irrigators Or Spray Devices", relates to a spray device for distribution and injection of medication and cleaning preparations antibody cavities. The invention includes a spray tube which is readily detachable secured to a speculum but the second end of the tube may be coupled to a spring container.
U.S. Pat. No. 3,830,225, issued to Shinnick, entitled "Multi-Purpose Stop Cock Arrangement For Sucking Injection Oxygen Cessory Equipment", relates to a bronchoscope which allows the introduction or removal of fluid or instruments or both without withdrawing the other equipment from the bronchoscope.
Other art pertinent to the present invention is the Stack House Abdominal Smoke Control Valve which is a release system and valve that enables the laser surgeon to evacuate smoke from the inflated abdominal cavity during laser laparoscopy. The apparatus is manufactured and sold by Stack House Associates, Inc., which provides a filtration unit for the by-products from laser surgery of smoke and odor vaporized tissue through the use of a vacuum tube into the area of the laser. Such a filter would be used in conjunction with the present invention.
Applicant has presently pending entitled "Surgical Speculum", bearing Ser. No. 128,635, filed Dec. 4, 1987, now U.S. Pat. No. 4,884,559, which discloses a modified cervical speculum having upper and lower blades, the blades movable in relation to one another, the lower blade provided with a liquid evacuator tube built into the blade portion itself, with the top plate having a smoke evacuator tube for evacuating smoke from the patient. The tubes would end on their distal end and enter a trap in the handle portion with the speculum to evacuate the liquid and the smoke after surgery. The invention as disclosed in the present application would introduce a significant modification to that as disclosed in the earlier application, which provides for the adaptation of the filtration unit onto an existing cervical speculum.